BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHA NEPTUNE

    MDR report key: 4101859 · Received August 18, 2014

    Report

    Report Number
    3003898360-2014-00548
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT WOULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. PER DHR (DEVICE HISTORY RECORD), THE PRODUCT CONCHA NEPTUNE, LOT #607070253 WAS MANUFACTURED ON 03/18/2008. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES WERE REQUIRED. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE DEFECT. THE COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE HEATER FLASHES ON AND OFF AND THEN SHUTS OFF COMPLETELY. THE CUSTOMER ALSO ALLEGES THAT THERE ARE SOME CRACKS ON THE FOOT TOP OF THE UNIT. NO REPORT OF PT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493268 HUDSON CONCHA NEPTUNE HEATED HUMIDIFICATION SYSTEM BTT TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1